Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-03 @ 3:41 AM
Study NCT ID:
NCT01769157
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2013-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of L-carnitine on Hypothyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007037', 'term': 'Hypothyroidism'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002331', 'term': 'Carnitine'}], 'ancestors': [{'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-02', 'studyFirstSubmitDate': '2013-01-10', 'studyFirstSubmitQcDate': '2013-01-15', 'lastUpdatePostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'thyroid function test', 'timeFrame': 'baseline and 12 weeks', 'description': 'measure thyroid-stimulating hormone and free T4 at baseline and 12 weeks'}], 'primaryOutcomes': [{'measure': 'Fatigue Severity scale', 'timeFrame': 'baseline and 12 weeks', 'description': "Change from Baseline in Fatigue severity scale at 12 weeks (scoring 'fatigue severity scale' at baseline and 12 weeks)"}], 'secondaryOutcomes': [{'measure': 'Wessely and Powell score', 'timeFrame': 'baseline and 12 weeks', 'description': "Change from Baseline in Wessely and Powell score at 12 weeks (scoring 'Wessely and Powell score' at baseline and 12 weeks)"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hypothyroidism']}, 'referencesModule': {'references': [{'pmid': '27432821', 'type': 'DERIVED', 'citation': 'An JH, Kim YJ, Kim KJ, Kim SH, Kim NH, Kim HY, Kim NH, Choi KM, Baik SH, Choi DS, Kim SG. L-carnitine supplementation for the management of fatigue in patients with hypothyroidism on levothyroxine treatment: a randomized, double-blind, placebo-controlled trial. Endocr J. 2016 Oct 29;63(10):885-895. doi: 10.1507/endocrj.EJ16-0109. Epub 2016 Jul 16.'}]}, 'descriptionModule': {'briefSummary': 'L-carnitine and thyroid hormone tended to antagonize reciprocally in human body. Urinary excretion of L-carnitine decreased in hypothyroid patients, and levothyroxine supplementation increased excretion of L-carnitine. The investigators hypothesized that supplying L-carnitine to hypothyroid patients with fatigue symptom could improve the quality of life, and fatigue score in them. Therefore, the investigators planned to compare the efficacy of L-carnitine and placebo in hypothyroid patients who had taken levothyroxine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of hypothyroidism with fatigue symptom\n* Currently use of the same amount of levothyroxine over at least six months\n* Normal serum free T4 level\n\nExclusion Criteria:\n\n* Current smoker\n* Serum hemoglobin level of under 12mg/dL\n* Clinical diagnosis of diabetes mellitus or fasting serum glucose level ≥ 126mg/dL or HbA1c level ≥ 6.5%\n* History of significant heart failure\n* History of large amount of alcohol consumption\n* Uncontrolled hypertension (systolic blood pressure ≥ 160 millimeter of mercury (mmHg) or diastolic blood pressure ≥ 100 mmHg\n* pregnant, or planning to be pregnant, or breast feeding women\n* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 times of normal limit\n* serum Cr level \\> 2.0mg/dL'}, 'identificationModule': {'nctId': 'NCT01769157', 'briefTitle': 'Effects of L-carnitine on Hypothyroidism', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': "Single-center, Randomized, Double-Blinded, Comparative Study of the Effectiveness of L-carnitine in Patients'Fatigue Degree Changing With Hypothyroidism Who Take Levothyroxine", 'orgStudyIdInfo': {'id': 'LC-TH-1101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'L-carnitine', 'description': 'L-carnitine 330mg, 3 tablet twice daily', 'interventionNames': ['Drug: L-carnitine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo drug, 3 tablet twice daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'L-carnitine', 'type': 'DRUG', 'armGroupLabels': ['L-carnitine']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'IlDong Pharmaceutical Co Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sin Gon Kim', 'investigatorAffiliation': 'Korea University Anam Hospital'}}}}